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Regenicin (OTC:RGIN) is completing validation of its NovaDerm skin substitute at a leading institute of technology in the U.S and plans to seek FDA approval to move into clinical trials in the second half of 2015 as well as file for worldwide designation of NovaDerm as an orphan product.

“We expect to be in the clinic before the end of the year at one or two of the 150 critical burn centers in the U.S.,” Randall McCoy, chairman and CEO, says in an interview with BioTuesdays.com.

The clinical trial is expected to enroll a minimum number of burn patients, with each patient completing treatment in three months. “We expect the FDA will ask us to monitor the patient for six months to see if we can obtain additional benefits about the performance of NovaDerm. That should put us on track to file for regulatory approval before the end of 2016,” he adds.

Mr. McCoy explains that NovaDerm is a regenerative cell therapy that has the potential to re-grow a patient’s own skin in a laboratory by harvesting fibroblast and keratinocytes from a skin biopsy that is a small fraction of the size of the damaged area of skin.

NovaDerm is composed of epidermal, or outer skin, and dermal, or inner skin, layers with an autologous extracellular matrix. A cell culturing process followed by meshing at the time of grafting could provide enough autologous skin to graft an area up to 200 times larger than the initial biopsy.

The NovaDerm graft also contains collagen produced by the patients’ own fibroblast during culturing. The autologous fibroblasts produce reticular and elastic fibers that make up the extracellular matrix.

“NovaDerm is expected to be the only autologous cultured skin substitute designated as a biologic by the FDA for treating burn victims with total burned surface areas greater than 30%,” Mr. McCoy contends.

Competitive skin products on the market were originally designated as medical devices but the FDA no longer considers them devices. Skin substitutes were put under the jurisdiction of the Biologics division in August 14, 2013.

NovaDerm: Composed of Both Epidermal and Dermal Skin Layers Supported by a Collagen Matrix

Mr. McCoy says NovaDerm is the first skin substitute that will go through the approval process as a biologic. “We do not expect the change in designation will have an impact on the requirements for FDA approval.”

In addition, he says NovaDerm is being developed to ensure the cultured skin substitute is available for grafting in less than a month, with a shelf life longer than one week. “We do this to ensure the product is ready when the patient is ready to receive NovaDerm,” he adds.

“We think our product has the potential to be far superior than what’s out there on the market,” he says, noting that NovaDerm also could be used for chronic wounds and skin ulcers.

According to the American Burn Association, there are currently over 2,000 cases annually involving chemical and thermal burns covering more than 50% of a patient’s total body surface.

Mr. McCoy points out that severe burns greater than 50% total burn surface area in the civilian population result in more than 900,000 hospital days in the U.S. annually, with the average hospital stay costing about $9,000 a day.

“Mortality and morbidity from burns, trauma, and other skin loss injuries remain significant medical and socio-economic problems estimated to cost more than $1-billion annually in treatment costs and lost productivity,” he adds.

Mr. McCoy suggests that in the U.S. alone, NovaDerm could be used to treat 40,000 patients a year, with burns covering over 30% of their body. NovaDerm is expected to reduce current treatment costs by more than $1-million for severe cases.

The American Medical Association has assigned a “current procedural terminology” code for cultured skin substitutes under the dermal substitute category, which enables insurance companies to process, and hospitals to be reimbursed for, cultured skin substitutes once approved by the FDA.

Small Harvested Section of a Patient’s Own Skin can be Grown to Graft an Area Up to 200X it Original Size

NovaDerm, like other regenerative skin candidates in development, are built on collagen scaffolds. “When we place fibroblasts on bovine collagen, the original bovine collagen is replaced with new human collagen produced by a patients’ own fibroblasts, when building a new cellular matrix.” Mr. McCoy explains.

However, most of the industry’s collagen supply comes from animals of unknown origins or medical history. In an effort to find safe traceable collagen supplies within the U.S. and abroad, Mr. McCoy says Regenicin will only enter into exclusive agreements with suppliers that produce collagen from closed herds.

The advantage of closed herds is that animals within the herd have much less exposure to potential carriers of diseases or parasites brought in from animals outside the herd.

Mr. McCoy points out that NovaDerm intends to be the first product of its kind to use a collagen matrix produced exceeding international and FDA closed-herd regulations. “NovaDerm is processed to mitigate the risk of contamination of unwanted pathogens in every step of the process,” he adds.

Regarding traditional treatments for chronic burns, Mr. McCoy notes from his own childhood experience that harvested areas of skin for grafts are just as painful as the initial burn site and that harvesting adds to the size of the open wound area and increases the chance of infection.

“If the patient is a child, skin grafts don’t grow with the patient and they need to go through the whole process again when they get older,” he adds.

Because NovaDerm is grown from a small section of a patient’s own skin cells and contains both the epidermal and dermal layers of skin, he says it is designed to provide an alternative to harvesting skin from multiple uninjured sites.

In addition, NovaDerm grows and stretches with the patient and decreases the risk of life threatening infections. Using autologous cells eliminates the need for a lifetime of taking immune suppressing drugs and lowers the risk of rejection.

“By scientific rationale, NovaDerm could be used for wound closure and reduce heath care costs,” he adds.

Mr. McCoy says the technology for NovaDerm was developed by studying the development of skin substitutes over the last 25 years. The skin substitute technologies that are the basis of the NovaDerm product have been clinically tested in numerous FDA sanctioned clinical trials by various companies, he adds.

“NovaDerm is intended to provide physicians and patients with a new, safer approach to skin regeneration, by using technologies that can protect the patient from external pathogens that might be found in traditional collagen-based products,” Mr. McCoy says.